NQF-Endorsed Measures for Renal Conditions, 2015

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NQF-Endorsed Measures

for Renal Conditions,

2015

TECHNICAL REPORT

December 2015

This report is funded by the Department of Health and Human Services under contract HHSM-500-2012-00009I Task Order HHSM-500-T0008

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NQF-Endorsed Measures for Renal Conditions, 2015

TECHNICAL REPORT

Executive Summary

Renal disease is a leading cause of morbidity and mortality in the United States. More than 20 million adults (10% of the population) in the United States have chronic kidney disease (CKD). Untreated CKD can result in end-stage renal disease (ESRD) and a host of other health complications. Currently, over half a million people in the United States have received a diagnosis of ESRD, the only chronic disease covered by Medicare for people under the age of 65. Considering the high mortality rates and high healthcare utilization and costs associated with ESRD, the need to focus on quality measures for patients with renal disease is particularly important.

On May 6-7, 2015, NQF convened a new multistakeholder Standing Committee composed of 23 individuals to evaluate 14 NQF-endorsed maintenance measures and 11 new measures and make recommendations for endorsement. Thirteen measures were recommended for endorsement; 3

measures were recommended for endorsement with reserve status; the Committee did not recommend 7 measures; and it did not reach consensus on 2 measures. During post-comment conference calls held on July 30 and August 3, 2015, the Standing Committee reviewed comments, measure updates, and several measure reconsideration requests. The final recommendations were as follows: 15 measures were recommended for endorsement; 4 measures were recommended for endorsement with reserve status; and the Committee did not recommend 6 measures. The CSAC and the Board upheld the Committee’s recommendations. The 15 endorsed measures are:

• 0251: Vascular Access—Functional Arteriovenous Fistula (AVF) or AV Graft or Evaluation for Placement (Kidney Quality Care Alliance – KCQA))

• 0256: Hemodialysis Vascular Access—Minimizing use of catheters as Chronic Dialysis Access (University of Michigan/Centers for Medicare & Medicaid Services – UM/CMS)

• 0257: Hemodialysis Vascular Access—Maximizing Placement of Arterial Venous Fistula (AVF) (UM/CMS)

• 0318: Peritoneal Dialysis Adequacy Clinical Performance Measure III - Delivered Dose of Peritoneal Dialysis Above Minimum (UM/CMS)

• 0321: Adult Kidney Disease: Peritoneal Dialysis Adequacy: Solute (Renal Physicians Association – RPA)

• 1423: Minimum spKt/V for Pediatric Hemodialysis Patients (UM/CMS) • 1424: Monthly Hemoglobin Measurement for Pediatric Patients (UM/CMS) • 1425: Measurement of nPCR for Pediatric Hemodialysis Patients (UM/CMS)

• 1460: Bloodstream Infection in Hemodialysis Outpatients (Centers for Disease Control and Prevention – CDC)

• 1662: Angiotensin Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy (RPA)

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• 1667: Pediatric Kidney Disease : ESRD Patients Receiving Dialysis: Hemoglobin Level <10g/dL (RPA)

• 2594: Optimal End Stage Renal Disease Starts (Kaiser)

• 2701: Avoidance of Utilization of High Ultrafiltration Rate (>/= 13 ml/kg/hour) (KCQA) • 2704: Minimum Delivered Peritoneal Dialysis Dose (UM/CMS)

• 2706: Pediatric Peritoneal Dialysis Adequacy: Achievement of Target Kt/V (UM/CMS) The following measures were endorsed with reserve status:

• 0249: Hemodialysis Adequacy Clinical Performance Measure III: Hemodialysis Adequacy—HD Adequacy—Minimum Delivered Hemodialysis Dose (UM/CMS)

• 0255: Measurement of Serum Phosphorus Concentration (UM/CMS) • 0323: Adult Kidney Disease: Hemodialysis Adequacy: Solute (RPA) • 1454: Proportion of patients with hypercalcemia (UM/CMS) The following measures were not endorsed:

• 1660: ESRD Patients Receiving Dialysis: Hemoglobin Level <10 g/dL (RPA)

• 2699: Anemia of Chronic Kidney Disease: Dialysis Facility Standardized Transfusion Ratio (UM/CMS)

• 2700: Ultrafiltration rate greater than 13 ml/kg/hr (UM/CMS) • 2702: Post-Dialysis Weight Above or Below Target Weight (KCQA) • 2703: Minimum Delivered Hemodialysis Dose (UM/CMS)

• 2705: Delivered Dose of Dialysis Above Minimum (UM/CMS)

Brief summaries of the measures reviewed in this project are included in the body of the report; detailed summaries of the Committee’s discussion and ratings of the criteria for each measure are in Appendix A.

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Introduction

Renal disease is a leading cause of morbidity and mortality in the United States. More than 20 million adults (10% of the population) in the United States have chronic kidney disease (CKD). It is associated with premature mortality, decreased quality of life, and increased healthcare costs. Risk factors for CKD include cardiovascular disease, diabetes, hypertension, and obesity.1_{Untreated CKD can result in} end-stage renal disease (ESRD). Currently, over half a million people in the United States have received a diagnosis of ESRD.

In 1972, President Richard Nixon signed section 2991 of Public Law 92–603, which established ESRD as the only healthcare condition to be covered under Medicare for people under the age of 65.2_{People are} eligible for Medicare regardless of their age if their kidneys are no longer functioning, if they need regular dialysis, or if they have had a kidney transplant. Considering the high mortality rates and high healthcare utilization and costs associated with ESRD, the need to focus on quality measures for patients with renal disease is particularly important. CKD and ESRD continue to cost the United States significant amounts for care and treatment. In 2010, total Medicare spending rose 6.5%, to $522.8 billion and expenditures for ESRD rose 8%, to $32.9 billion3_.

This project sought to identify and endorse performance measures for accountability and quality improvement that address conditions, treatments, interventions, or procedures relating to kidney disease. On May 6-7, 2015, NQF convened a new multistakeholder Standing Committee composed of 23 individuals to evaluate 14 NQF-endorsed maintenance measures and 11 new measures and make recommendations for endorsement.

NQF Portfolio of Performance Measures for Renal Conditions

The Renal Standing Committee (see Appendix D) oversees NQF’s portfolio of 40 renal measures. While most of those measures are part of the Renal Project, other measures related to renal conditions were designated as more appropriate for inclusion in other NQF projects such as Person- and Family-Centered Care, Endocrine, All-Cause Admissions and Readmissions, Care Coordination, Surgery, and

Cardiovascular.

The renal portfolio contains 10 process measures, 29 outcome measures, and 1 composite measure (see table below).

Table 1. NQF Renal Portfolio of Measures

Process Outcome Composite

Renal Project 7 20 0

Other Projects

(Endocrine, Person- and Family-Centered Care, etc.)

3 9 1

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National Quality Strategy

The National Quality Strategy (NQS) serves as the overarching framework for guiding and aligning public and private efforts across all levels (local, state, and national) to improve the quality of healthcare in the U.S. The NQS establishes the "triple aim" of better care, affordable care, and healthy

people/communities, focusing on 6 priorities to achieve those aims: Safety, Person and Family Centered Care, Communication and Care Coordination, Effective Prevention and Treatment of Illness, Best Practices for Healthy Living, and Affordable Care.

Improvement efforts for renal care are consistent with the NQS triple aim and align with several of the NQS priorities:

• Safety. The renal measure portfolio includes measures that assess specific aspects of care that promote patient safety. The measures focus on hypercalcemia, hemoglobin levels, and

bloodstream infections, which are all indicators of patient safety.

• Effective Prevention and Treatment of Illness. Although the incidence of chronic kidney and end-stage renal disease has showed slight decline in the past few years, the conditions continue to generate significant costs for the U.S. healthcare system.

• Person- and Family-Centered Care. There are two measures in the renal portfolio which have a person- and family-centered care focus: the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) and the Assessment of Quality of Life in Dialysis Patients.

Use of Measures in the Portfolio

Endorsement of measures by NQF is valued because the evaluation process is both rigorous and transparent, but also because evaluations are conducted by multistakeholder committees composed of clinicians and other experts representing the healthcare spectrum, including healthcare providers, employers, health plans, public agencies, community coalitions, and patients—many of whom use measures on a daily basis to ensure better care. Moreover, NQF-endorsed measures undergo routine "maintenance" (i.e., re-evaluation) to ensure that they are still the best available measures and reflect the current science. Importantly, federal law requires that preference be given to NQF-endorsed measures for use in federal public reporting and performance-based payment programs. NQF measures also are used by a variety of stakeholders in the private sector, including hospitals, health plans, and communities.

The measures considered in this Renal Project are being implemented at various levels within the healthcare system. Many of the new measures are in use in internal quality improvement efforts or have been developed for consideration for use in federal programs in the future. The majority of measures under consideration for maintenance endorsement are in use in the CMS ESRD Quality Incentive Program (QIP) and are used for Dialysis Facility Compare. See Appendix C for details of federal program use for the measures in the portfolio that were reviewed in this project.

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Committee Input on Gaps in the Portfolio

The Committee identified numerous areas where additional measure development is needed. The following concepts, if developed into measures, could potentially contribute to improving quality of care for renal patients:

• Transitions in care –particularly for teens and adolescents and patients who transition from transplant back to requiring renal replacement

• Palliative therapy/comfort therapy – patient-focused measures where the goal is not curative • Patient Experience of Care – Consumer Assessment of Healthcare Providers & Systems (CAHPS)

(expand beyond In-Center Hemodialysis [ICH]), Kidney Disease Quality of Life Instrument (KDQOL), and Depression Screening

• Informed decisionmaking for ESRD pregnant patients about birth control and family planning • Oral Medications – medicine reconciliation, appropriateness of medications

• Transplant patients – especially for longer follow-up post-transplant • Incident versus prevalent patients (i.e., patients newly diagnosed) • Patient engagement and actual participation in plan of care • Infection associated with peritoneal dialysis

• Anxiety as a comorbidity • Staffing ratios in dialysis centers • Malnutrition

Renal Measure Evaluation

On May 6-7, 2015, the Renal Standing Committee evaluated 11 new measures and 14 measures

undergoing maintenance review against NQF’s standard evaluation criteria. To facilitate the evaluation, the Committee and candidate standards were divided into 4 workgroups for preliminary review against the evaluation subcriteria prior to consideration by the entire Standing Committee. On July 30 and August 3, 2015, and post-public comment, the Standing Committee met to review comments, the measures where consensus was not reached, and reconsideration requests for 6 of the 7 measures that were not recommended. The Committee’s discussion and ratings of the criteria are summarized in Appendix A.

Table 2. Renal Measure Evaluation Summary

Maintenance New Total

Measures under consideration 14 11 25

Measures withdrawn from consideration

before the Committee met 5 0 5

Measures endorsed 9 6 15

Measures endorsed with reserve status 4 0 4

Measures not recommended for

endorsement 0 6 6

Reasons for not recommending Importance – 0 Scientific Acceptability – 0 Overall – 0 Importance – 3 Scientific Acceptability – 1 Overall – 2 Importance – 3 Scientific Acceptability – 1 Overall – 2

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Comments Received Prior to Committee Evaluation

NQF solicits comments on endorsed measures on an ongoing basis through the Quality Positioning System (QPS). In addition, NQF solicits comments prior to the evaluation of the measures via an online tool located on the project webpage. For this evaluation cycle, the pre-evaluation comment period was open from March 23 to April 10, 2015, for 18 of the 25 measures under review. Comments on four dialysis measures stewarded by Renal Physicians Association (RPA), the target weight measure stewarded by Kidney Care Quality Alliance (KCQA), the bloodstream infection measure stewarded by Centers for Disease Control and Prevention (CDC) and the optimal starts measure stewarded by Kaiser Permanente were not requested because measure submission materials could not be posted during this period. A total of 52 pre-evaluation comments were received (see Appendix E).

All submitted comments were provided to the Committee prior to its initial deliberations held during the workgroup calls and in-person meeting.

Comments Received After Committee Evaluation

The draft report went out for public and member comment June 12 through July 13, 2015. During this commenting period, NQF received 97 comments from 5 organizations.

A complete table of comments submitted pre- and post-evaluation, along with the responses to each comment and the actions taken by the Standing Committee, is posted to the project page on the NQF website, along with the measure submission forms.

Overarching Issues

During the Standing Committee’s discussion of the measures, several overarching issues emerged that were factored into the Committee’s ratings and recommendations for multiple measures and are not repeated in detail with each individual measure.

Current Implementation and Use

During the review of the measures, the Committee noted that many measures being considered for re-endorsement and even some undergoing initial evaluation are not currently in use and that the

developer has not indicated a future intended use for the measure. For previously endorsed measures, the developers pointed out that the measures are available to the general public to use for internal quality improvement even if they are not currently in use in federal programs. For new measure submissions, the developers indicated that many measures are developed prior to rulemaking, during which endorsement is a consideration when finalizing measures for use in federal programs. While the Committee considered current implementation an important criterion, lack of use in federal programs was not considered a barrier to endorsement.

Use of Reserve Status

Some measures submitted for maintenance evaluation were determined to be important indicators of quality, however, were “topped out” in performance. These measures often failed the NQF performance gap subcriterion. The Committee indicated interest in considering them as suitable for recommendation

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for endorsement with reserve status. The purpose of an endorsement with reserve status is to retain endorsement of reliable and valid quality performance measures that have overall high levels of performance with little variability. In order to be considered for reserve status, the measure must pass all other NQF criteria, and the Committee must anticipate that performance may deteriorate if the measure is not monitored. The Committee considered one measure where a lower score was indicative of better quality and had difficulties interpreting the use of reserve status, and if a measure “floor” and “ceiling” should be considered consistently. They suggested that measures of patient safety, where lower scores are optimal, may require different criteria for evaluation.

Level of Evidence and Population Size: Pediatric Measures

The Committee reviewed measures with a primary focus on the pediatric population, as well as some that focused more broadly on pediatric and adult ESRD patients combined. The Committee noted that, for the majority of pediatric measures, evidence is largely based on inference from adult data that adequate treatment will result in better outcomes. There was consensus within the Committee that performance measures for adults should serve as the minimum standard where pediatric-specific data do not exist. Overall, the Committee agreed that this was acceptable due to the small size of pediatric patient population being served by any specific clinician or dialysis facility. One developer indicated that there is a minimum denominator sample size of 11 patients required for any publicly reported data. Since some facilities cannot reach this threshold, adult and pediatric combined measures were brought forward by the developer to assist pediatric patients in facilities that did not meet the 11-patient requirement. The Committee voiced concerns that measures with these combined populations may not be equally supported by the evidence and testing provided. Specific issues raised with each measure are detailed in Appendix A.

CROWNWeb Data

CROWNWeb is a Web-based data-collection system implemented in 2012 that allows Medicare-certified dialysis facilities in the United States to safely and securely submit administrative and clinical data to CMS.4_{The Committee requested clarity around data issues with CROWNWeb, specifically regarding} collection of specific data required for measure calculation, including vascular access. The Committee raised a specific concern related to the impact of data collection errors on gap and other analyses, especially related to missing patient data. The developer responded that it believes that missing data is not resulting in errors and provided analysis that demonstrated reliability between CROWNWeb and Medicare claims.

Summary of Measure Evaluation

The following brief summaries of the measure evaluation highlight the major issues that were

considered by the Committee. Details of the Committee’s discussion and ratings of the criteria for each measure are in Appendix A.

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Endorsed Measures

0251 Vascular Access—Functional Arteriovenous Fistula (AVF) or AV Graft or Evaluation for Placement (Kidney Care Quality Alliance): Endorsed

Description: Percentage of end stage renal disease (ESRD) patients aged 18 years and older receiving hemodialysis during the 12-month reporting period and on dialysis >90 days who: 1. have a functional autogenous AVF (defined as two needles used or a single-needle device [NOT one needle used in a two-needle device]) (computed and reported separately); 2. have a functional AV graft (computed and reported separately); or 3. have a catheter, but have been seen/evaluated by a vascular surgeon, other surgeon qualified in the area of vascular access, or interventional nephrologist trained in the primary placement of vascular access for a functional autogenous AVF or AV graft at least once during the 12-month reporting period (computed and reported separately). Reporting should be stratified by incident versus prevalent patients, as defined by the United States Renal Data System (USRDS); Measure Type: Process; Level of Analysis: Clinician: Individual; Setting of Care: Ambulatory Care : Clinician Office/Clinic, Dialysis Facility; Data Source: Administrative claims, Electronic Clinical Data, Electronic Clinical Data : Electronic Health Record, Paper Medical Records

This measure was originally endorsed in 2007 and was re-endorsed in 2011. It is specified at the clinician level. Although this measure is currently not in use, the developer stated that there are plans to use it in public reporting and payment programs, and also plans to use it in quality improvement with external benchmarking to multiple organizations. The measure can be monitored through Current Procedural Terminology (CPT) codes, end-stage renal disease diagnosis codes from the International Classification of Diseases (ICD-9 and ICD-10), and G-codes for hemodialysis. The evidence base for the measure is derived from the Kidney Disease Outcomes Quality Initiative (KDOQI) 2006 guideline update for vascular access, which has a grade of B. The Committee noted the evidence on the vascular side for

arteriovenous fistulas and grafts is stronger than the evidence on the impact on quality from a referred and assumed visit with the vascular surgeon for reassessment. The Committee considered validity and use of G-codes for measure calculation, and also noted that the data supplied by the developer on chart validation results showed high validity for sensitivity, specificity, positive predictive value, and negative predictive value. In addition, data indicated there was a meaningful difference between minimum and maximum scores. Upon consideration of the evidence, measure mechanics and testing data, the Committee recommended the measure for endorsement.

0256 Minimizing Use of Catheters as Chronic Dialysis Access (University of Michigan/Centers for Medicare & Medicaid Services): Endorsed

Description: Percentage of patient months on maintenance hemodialysis during the last HD treatment of month with a chronic catheter continuously for 90 days or longer prior to the last hemodialysis session; Measure Type: Intermediate Clinical Outcome; Level of Analysis: Facility; Setting of Care: Dialysis Facility; Data Source: Administrative claims, Electronic Clinical Data

This measure was originally endorsed in 2007 and was re-endorsed in 2011. It is specified at the facility level. The measure is publicly reported in Dialysis Facility Compare (DFC) and is used in a payment program, ESRD QIP. The evidence presented indicates alignment with the 2006 update of the KDOQI Vascular Access Clinical Practice Guidelines. The measure is an intermediate outcome measure which

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reports the percentage of adult patient months on maintenance hemodialysis for patients on maintenance hemodialysis during the last treatment of the month, and that have a chronic catheter continuously for 90 days or longer prior to the last hemodialysis session. When paired with fistula measure #0257, the goal of the catheter measure is to encourage further reduction in chronic catheter use. The developer provided January 2013-December 2013 CROWNWeb performance data indicating that the rate of minimizing catheter use is about 90%. The Committee agreed that there is room for improvement and disparities in care. The Committee found the data supplied by the developer supported the reliability, validity, and feasibility of the measure and supported the measure for endorsement.

0257 Maximizing Placement of Arterial Venous Fistula (AVF) (University and Michigan/Centers for Medicare & Medicaid Services): Endorsed

Description: Percentage of patient months for patients on maintenance hemodialysis during the last HD treatment of month using an autogenous AV fistula with two needles; Measure Type: Intermediate Clinical Outcome; Level of Analysis: Facility; Setting of Care: Dialysis Facility; Data Source:

Administrative claims, Electronic Clinical Data

This measure was originally endorsed in 2007 and was re-endorsed in 2012. It is specified at the facility level. The measure reports the percentage of adult patient months for ESRD patients on maintenance hemodialysis during the last treatment of the month using an endogenous AV fistula with 2 needles. When paired with the catheter measure #0256, the intent of the measure is to recognize facility efforts to increase fistula use as primary vascular access. This measure treats fistula use as a positive outcome, prolonged use of channel catheter as a negative outcome, and AV graft use as neutral. The Committee noted the evidence supporting the measure is supported by clinical guidelines as well as a significant number of articles and studies. However, the Committee would have liked to have seen data related to exceptions to placement of an AVF either due to patient circumstances (e.g., age) or patient preference. The developer noted that many of the concerns raised by the Committee are under consideration for possible revision to the measure in the future. After consideration of all the endorsement criteria, the Committee recommended this measure for continued endorsement. They also indicated a strong interest in being kept apprised of potential revisions that strengthen the measure construct. 0318 Delivered Dose of Peritoneal Dialysis Above Minimum (University of Michigan/Centers for Medicare & Medicaid Services): Endorsed

Description: Percentage of all patient months for patients = 18 whose delivered peritoneal dialysis dose was a weekly Kt/Vurea of between spKt/V >= 1.7 and spKt/V =< 8.5. (dialytic + residual); Measure Type: Intermediate Clinical Outcome; Level of Analysis: Facility; Setting of Care: Dialysis Facility; Data Source: Administrative claims, Electronic Clinical Data

This intermediate clinical outcome measure was originally endorsed in 2007. It is specified at the facility level. The measure is used in Dialysis Facility Compare for public reporting and the ESRD Quality

Incentive programs. The intent of the measure is to evaluate peritoneal dialysis adequacy to ensure frequent adequacy measurement and adequate dialysis dosing, as both have been linked to improved patient outcomes. Committee members noted that the evidence supports the lower bound (spKt/V >= 1.7), but lacks evidence to support the upper bound (spKt/V >= 8.5). The developer clarified that the

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upper bounds were included in the specifications as an administrative means of ensuring that the data integrity was maintained, and to be transparent with how the measure is calculated. The Committee recommended that the upper bound be removed, and the developer agreed to make the change. At the post-comment call, the developer confirmed that the requested change had been made. Upon

considering the stipulated revision to the measure, as well as data provided on reliability, validity, and feasibility, the Committee recommended the measure for continued endorsement.

0321 Adult Kidney Disease: Peritoneal Dialysis Adequacy: Solute (Renal Physicians Association): Endorsed

Description: Percentage of patients aged 18 years and older with a diagnosis of End Stage Renal Disease (ESRD) receiving peritoneal dialysis who have a total Kt/V >= 1.7 per week measured once every 4 months; Measure Type: Intermediate Clinical Outcome; Level of Analysis: Clinician : Group/Practice, Clinician : Individual, Clinician : Team; Setting of Care: Ambulatory Care : Clinician Office/Clinic, Dialysis Facility, Home Health, Post Acute/Long Term Care Facility : Nursing Home/Skilled Nursing Facility, Other; Data Source: Administrative claims, Electronic Clinical Data, Electronic Clinical Data : Electronic Health Record, Electronic Clinical Data : Registry

This intermediate clinical outcome measure was originally endorsed in 2007. It is specified at the clinician level. The measure is used in public reporting, and in payment and quality improvement programs (PQRS, Physician Compare, and RPA Internal Quality Improvement initiatives). The rationale for the measure is that an adequate dialysis dose is linked to improved health outcomes such as attaining highest quality of life after onset of illness, decreasing morbidity and mortality, and increasing treatment effectiveness. The Committee indicated that it would be helpful to have clarity on how long the residual kidney function is allowed to carry forward, and to have a drop date for the total Kt/V calculation (e.g., 3 or 4 months). At the post-comment call, the developer confirmed that the measure now clarified that residual function is measured every 4 months. Committee members discussed whether having a minimum number of 11 patients included in the denominator would make the measure more meaningful and could reduce variance, similar to how the facility level measures are specified. Although Committee members noted that they would like to see more data to support the minimum sample size for clinicians in the future, the Committee agreed that the measure is suitable for continued endorsement.

1424 Monthly Hemoglobin Measurement for Pediatric Patients (University of Michigan/Centers for Medicare & Medicaid Services): Endorsed

Description: Percentage of patient months of pediatric (less than 18 years) in-center hemodialysis, home hemodialysis, and peritoneal dialysis patients who have monthly measures for hemoglobin during the reporting period; Measure Type: Process; Level of Analysis: Facility; Setting of Care: Dialysis Facility; Data Source: Electronic Clinical Data

This measure was originally endorsed in 2011. It is specified at the facility level. The Committee accepted evidence provided by the developer and noted a systematic review summary that was

supportive of the measure. With a mean performance score of 75%, the Committee acknowledged there was a performance gap. While the Committee expressed some concerns over the small sample size for pediatric practices and CROWNWeb data transmission issues, the Committee concluded that overall this

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measure was reliable and valid. The Committee agreed that the measure was feasible; however, it had concerns about the measure not currently being in use. The developer clarified that, while not currently used in public programs, the measure is available for use in quality improvement efforts.

1423 Minimum spKt/V for Pediatric Hemodialysis Patients (University of Michigan/Centers for Medicare & Medicaid Services): Endorsed

Description: Percentage of patient months for all pediatric (<18 years old) in-center HD patients who have been on hemodialysis for more than 90 days and dialyzing 3 or 4 times weekly whose average delivered dose of hemodialysis using the UKM or Daugirdas II formula) was between spKt/V = 1.2 and spKt/V<5.0; Measure Type: Intermediate Clinical Outcome; Level of Analysis: Facility; Setting of Care: Dialysis Facility; Data Source: Administrative claims, Electronic Clinical Data

This intermediate clinical outcome measure was originally endorsed in 2011. It is specified at the facility level. The measure is currently publicly reported in Dialysis Facility Compare and in the ESRD OIP

payment program. The Committee had much discussion about the evidence and did not reach consensus on this subcriterion. Committee members questioned the evidence supporting the upper limit (spKt/V<5). In addition, they raised concerns about the evidence supporting dialyzing 3 times and not 4 times per week. The Committee did not reach consensus on reliability. There were concerns about the measure as constructed—specifically using a single pool Kt/V in patients dialyzed at different

frequencies. Members noted that the urea kinetic modelling (UKM) or Daugirdas formulas are designed for a fixed number of dialysis treatments a week. Committee members noted that when looking at varying frequencies of dialysis, rather than using a single pool Kt/V, the tool that should be used is a continuous tool, such as the standard Kt/V. Committee members also raised concerns that setting a minimum of 1.2 Kt/V with whatever frequency could be a disincentive to put patients on increasing frequency of dialysis. Consensus was not reached during the in-person meeting when voting on overall suitability for continued endorsement. Based on the updates provided by the developer during the July 30 post-comment call, the Committee was able to reach consensus on this measure and ultimately recommended the measure for endorsement.

1425 Measurement of nPCR for Pediatric Hemodialysis Patients (University of Michigan/Centers for Medicare & Medicaid Services): Endorsed

Description: Percentage of patient months of pediatric (less than 18 years old) in-center hemodialysis patients (irrespective of frequency of dialysis) with documented monthly nPCR measurements; Measure Type: Process; Level of Analysis: Facility; Setting of Care: Dialysis Facility; Data Source: Electronic Clinical Data

This measure was originally endorsed in 2011. It is specified at the facility level. While the Committee acknowledged that the evidence and performance gap data were based on the adult population, Committee members concluded that the evidence and performance gap could be inferred to in the pediatric population. Based on the data provided by the developer, the Committee agreed that the measure is reliable and valid. The Committee agreed that the measure was feasible, however, had concerns about the measure not currently being in use. The developer clarified that, while not currently used in public programs, the measure is available for use in quality improvement efforts.

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1460 Bloodstream Infection in Hemodialysis Outpatients (Centers for Disease Control and Prevention): Endorsed

Description: Adjusted ranking metric (ARM) and Standardized Infection Ratio (SIR) of Bloodstream Infections (BSI) will be calculated among patients receiving hemodialysis at outpatient hemodialysis centers; Measure Type: Outcome; Level of Analysis: Facility, Population : National, Population: Regional, Population: State; Setting of Care: Dialysis Facility; Data Source: Electronic Clinical Data, Electronic Clinical Data: Electronic Health Record, Electronic Clinical Data: Imaging/Diagnostic Study, Electronic Clinical Data: Laboratory, Paper Medical Records, Electronic Clinical Data: Pharmacy

This is a facility-level outcome measure originally endorsed in 2011. The original measure reported the Standardized Infection Ratio (SIR), and the initial submission for this cycle of review added the Adjusted Ranking Metric (ARM) for patients who receive hemodialysis at outpatient hemodialysis facilities. The evidence provided states that use of this measure is demonstrated to assist in identifying outbreaks of bloodstream infections, to stimulate improvements in vascular access care, and to stimulate

improvements in other infection control practices that have led to subsequent reductions in

bloodstream infections. The Committee indicated the evidence for the SIR remains as strong today as at the original endorsement. While the SIR component of the measure is in current use and reported via the ESRD QIP, the performance data provided were outdated. The developer stated that it is currently analyzing data from the ESRD QIP and should be able to update performance and trend data in the near future. The Committee identified challenges in fully evaluating both the ARM and SIR components of the measure. While the SIR component is fully specified and tested, the developer acknowledged that the ARM methodology was still being finalized, but requested review and consideration of endorsement for both components. In the absence of detailed specifications and methodology on the ARM, the

Committee did not recommend the measure, as currently submitted, for continued endorsement. Members of the Committee encouraged developers to use a broad standardization methodology rather than using access type alone. Taking into account the Committee’s concerns about the ARM aspect of the measure, the developer removed it from the measure. After this update, the Committee changed its decision and recommended this measure for endorsement.

1662 Angiotensin Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy (Renal Physicians Association): Endorsed

Description: Percentage of patients aged 18 years and older with a diagnosis of CKD (not receiving RRT) and proteinuria who were prescribed ACE inhibitor or ARB therapy within a 12-month period; Measure Type: Process; Level of Analysis: Clinician: Group/Practice, Clinician: Individual, Clinician: Team; Setting of Care: Ambulatory Care: Clinician Office/Clinic, Dialysis Facility, Home Health, Post Acute/Long Term Care Facility: Nursing Home/Skilled Nursing Facility, Other; Data Source: Administrative claims, Electronic Clinical Data, Electronic Clinical Data: Electronic Health Record, Paper Medical Records, Electronic Clinical Data: Registry

This newly submitted process measure is specified at the clinician level. The measure is currently used for quality improvement in the RPA Kidney Quality Improvement Registry. The measure has planned use in public reporting and in a professional certification or recognition program. The developers provided full specifications on the measure and defined data elements. Data abstracted from patient records in

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2008 were used to calculate an inter-rater reliability of the measure. This analysis included a 93.15% agreement and kappa statistic of 0.8047 with the 95% confidence interval between 0.6395-0.9699 to adjust for chance agreement. Committee members noted that the specifications of the measure were well defined and precisely specified and agreed to recommend the measure for endorsement. Data were presented from the CMS Physician Quality Reporting Initiative (PRQI) claims option and in 2008, 45% of patients failed to receive optimal care, and significant variations in performance were noted in the program.

1667 Pediatric Kidney Disease : ESRD Patients Receiving Dialysis: Hemoglobin Level < 10g/dL (Renal Physicians Association): Endorsed

Description: Percentage of calendar months within a 12-month period during which patients aged 17 years and younger with a diagnosis of End Stage Renal Disease (ESRD) receiving hemodialysis or peritoneal dialysis have a hemoglobin level < 10 g/dL; Measure Type: Outcome; Level of Analysis: Clinician: Group/Practice, Clinician: Individual, Clinician: Team; Setting of Care: Ambulatory Care : Clinician Office/Clinic, Dialysis Facility, Home Health, Post Acute/Long Term Care Facility: Nursing Home/Skilled Nursing Facility, Other; Data Source: Administrative claims, Electronic Clinical Data, Electronic Clinical Data: Electronic Health Record, Electronic Clinical Data: Registry

This measure was originally endorsed in 2012 and is specified at the clinician level. The measure is currently used in the CMS Physician Compare and Physician Quality Reporting System (PQRS) programs, and is also used by the RPA Kidney Quality Improvement Registry. The Committee agreed there was strong evidence that a hemoglobin level below 10 results in adverse outcomes for children and that there was an opportunity for improvement with literature suggesting approximately 20% of patients currently live with levels below 10 gm/dL. Committee members voiced concern that the measure was not tested in children, the target population of this measure. Also, the kappa listed was for a data element that was no longer in the measure; hence, the Committee noted it was not relevant to the review of this measure. Initially, the Committee voted not to pass the measure on reliability. After further discussion and clarification from the developer that the reliability testing results would not change if tested in a pediatric population, the Committee requested to re-vote and passed the measure on reliability. After consideration of validity, feasibility, and use and usability, the Committee voted to recommend the measure for continued endorsement.

2594 Optimal End Stage Renal Disease (ESRD) Starts (The Permanente Federation): Endorsed Description: Optimal End Stage Renal Disease (ESRD) Starts is the percentage of new ESRD patients during the measurement period who experience a planned start of renal replacement therapy by receiving a preemptive kidney transplant, by initiating home dialysis, or by initiating outpatient in-center hemodialysis via arteriovenous fistula or arteriovenous graft; Measure Type: Process; Level of Analysis: Integrated Delivery System, Population: Regional, Clinician: Team; Setting of Care: Ambulatory Care: Clinician Office/Clinic, Dialysis Facility; Data Source: Administrative claims, Electronic Clinical Data, Electronic Clinical Data: Electronic Health Record, Electronic Clinical Data: Registry

This is a newly submitted measure for endorsement and is specified at the clinician and system levels. The measure is currently in use within the Kaiser Permanente integrated delivery system. The developer

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submitted clinical guidelines and systematic evidence reviews to support each component of the

measure. Based on the evidence submitted, the Committee indicated that overall the measure evidence could be graded as moderate. In addition, the developer data suggest a performance gap both within an integrated delivery system and the broader U.S. that supports the need for a national performance measure. The primary concerns raised about the measure specifications and reliability were regarding length of time new patients are under a nephrologist’s care, and the inclusion of elderly and pediatric patients in the measure population. At the post-comment call, the developer confirmed pediatric patients were removed from the measure’s population. Upon review of the reliability and validity testing data submitted, the Committee agreed that the testing demonstrated the scientific acceptability of the measure. Overarching discussion about the feasibility and usability of the measure focused on adaptation beyond the Permanente Federation and potential for implementation via use of claims, registry, and CROWNWeb data. The developer indicated that it would welcome conversations with CMS to explore broader implementation. Given the sufficient evidence, reliability, validity, and meeting the full NQF criteria, the Committee recommended Optimal ESRD Starts for endorsement.

2701 Avoidance of Utilization of High Ultrafiltration Rate (>/= 13 ml/kg/hour) (Kidney Care Quality Alliance): Endorsed

Description: Percentage of adult in-center hemodialysis patients in the facility whose average

ultrafiltration rate (UFR) is >/= 13 ml/kg/hour; Measure Type: Intermediate Clinical Outcome; Level of Analysis: Facility; Setting of Care: Other; Data Source: Electronic Clinical Data

This is a newly submitted measure specified at the facility level. The measure is intended to assess the percentage of adult in-center hemodialysis patients whose average ultrafiltration rate (UFR) is greater than or equal to 13 ml/kg per hour. During the workgroup review, there were questions about the time component in the numerator. KCQA considers the time component a critical element. Rather than dictating the UFR remain at or below 13, the length of the session component of the measure allows judicious use of UFR rates above 13 as long as the patient is dialyzed for more than 240 minutes. Upon review of the evidence, the Committee noted that in practice, if UFR is the sole focus, regardless of the timeframe some patients may require significantly longer dialysis treatments (beyond four hours), increasing the chance that they may refuse treatment. The time component is also necessary to avoid potential adverse unintended consequences of implementing the measure. The developer provided evidence including a KDOQI Guideline. The Committee noted that some patients need to have extended hemodialysis times and slower UFR. In addition, a literature review was provided that further supports the evidence. The Committee considered the clarity of the specifications and the reliability and validity testing results and recommended the measure for endorsement. The one area of concern raised was related to usability and whether the measure could eventually be implemented via CROWNWeb. The developer indicated that it is in discussions with CMS about this matter, and that the measure is currently in use for quality improvement efforts.

2704 Minimum Delivered Peritoneal Dialysis Dose (University of Michigan/Centers for Medicare & Medicaid Services): Endorsed

Description: Percentage of all patient months whose delivered peritoneal dialysis dose was a weekly Kt/Vurea of between spKt/V >= 1.7 (adult) or 1.8 (pediatric) and spKt/V =< 8.5. (dialytic + residual);

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Measure Type: Intermediate Clinical Outcome; Level of Analysis: Facility; Setting of Care: Dialysis Facility; Data Source: Administrative claims, Electronic Clinical Data

This newly submitted intermediate clinical outcome measure is specified at the facility level. It is a combination of the individual adult and pediatric Kt/V measures. The existing NQF-endorsed adult peritoneal Kt/V measure (#0318) is currently publicly reported. Both the existing measure #0318 and the new pediatric peritoneal Kt/V measure (#2706) are under review by the Committee. The existing

measure has been finalized for payment year (PY) 2018 in the ESRD Quality Incentive Program. The measures were bought forward separately, but the developer indicated that this measure could replace the two separate measures in the future. The measure focuses on peritoneal dialysis dosing adequacy every 4 months (adults) and 6 months (children) for ESRD dialysis patients. Committee members noted that although the evidence is not as strong for the pediatric population and is based on expert opinion, no large scale clinical trials have been conducted in the pediatric peritoneal dialysis population.

Members questioned if there is a difference between the 1.7 Kt/V and 1.8 Kt/V clearance thresholds (in evidence) with children and adults and why there are multiple measures. The developer clarified that it does not report on measures at facilities with fewer than 11 patients for patient identification reasons, and that many facilities have fewer than 11 patients. Combining adult and pediatric patients into one measure would allow more facilities to report on peritoneal dialysis adequacy. The Committee agreed that the measure is suitable for endorsement.

2706 Pediatric Peritoneal Dialysis Adequacy: Achievement of Target Kt/V (University of Michigan/Centers for Medicare & Medicaid Services): Endorsed

Description: Percent of pediatric peritoneal dialysis patient-months whose delivered peritoneal dialysis dose was a weekly Kt/Vurea of between spKt/V = 1.8 and spKt/V< 8.5. (dialytic + residual); Measure Type: Intermediate Clinical Outcome; Level of Analysis: Facility; Setting of Care: Dialysis Facility; Data Source: Administrative claims, Electronic Clinical Data

This newly submitted intermediate clinical outcome measure is specified at the facility level. This is a new measure that is not currently in use; however, the measure has been finalized for use in payment year (PY) 2018 ESRD QIP. This measure focuses on pediatrics, and the developers state that pediatric peritoneal adequacy targets should be no lower than existing adult peritoneal adequacy targets; generally, pediatric patients’ greater metabolic demands require higher adequacy targets in terms of small solute clearance. The Committee raised concerns about the specifications as they were provided in the submission form. The Committee expressed concern that the interval of measurement should be specified, that residual renal function should be measured using urea clearance and not combined creatine and urea clearance, and that the Kt/Vurea minimum should be changed from spKt/V >= 1.8 to spKt/V >= 1.7. The developer made the changes to the measure, and the Committee agreed that the measure is suitable for endorsement.

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Measures Endorsed with Reserve Status

0249 Delivered Dose of Hemodialysis Above Minimum (University of Michigan/Centers for Medicare & Medicaid Services): Endorsed with Reserve Status

Description: Percentage of all patient months for adult patients (>= 18years old) whose average delivered dose of hemodialysis (calculated from the last measurements of the month using the UKM or Daugirdas II formula) was between spKt/V >= 1.2 and spKt/V =< 5.0; Measure Type: Intermediate Clinical Outcome; Level of Analysis: Facility; Setting of Care: Dialysis Facility; Data Source: Administrative claims, Electronic Clinical Data

This measure was originally endorsed in 2007 and is specified at the facility level. The measure is currently reported in the Dialysis Facility Compare public program and the ESRD OIP payment program. The Committee agreed that there is strong evidence that supports the association between low spKt/V and increased mortality. Upon review of the data provided on the performance gap, the Committee agreed that there is not much room for improvement, and the measure did not pass this subcriterion. However, the Committee agreed that the measure is a good candidate for endorsement with reserve status. The Committee requested that the upper threshold of spKt/v <= 5.0 be removed as there is a lack of evidence to support this, and the developer agreed to make the change. Upon consideration of the evidence, measure mechanics, and testing data, the Committee recommended the measure for endorsement with reserve status.

0255 Measurement of Serum Phosphorus Concentration (University of Michigan/Centers for Medicare & Medicaid Services): Endorsed with Reserve Status

Description: Percentage of all peritoneal dialysis and hemodialysis patient months with serum or plasma phosphorus measured at least once within the month; Measure Type: Process; Level of Analysis: Facility; Setting of Care: Dialysis Facility; Data Source: Electronic Clinical Data

The measure was originally endorsed in 2007 and was re-endorsed in 2012. It is specified for use at the facility level. The Committee noted that while this is a process measure focused on monthly assessment of patient serum or plasma phosphorus, the evidence provided was not in direct alignment. Specifically, the KDIGO guidelines state that for CKD, phosphorous levels should be measured every 1 to 3 months and the measure indicates a monthly phosphorous level. The Committee rated the evidence for this measure as moderate. The Committee found that the testing data supplied by the developer

demonstrated adequate reliability, validity, and feasibility of the measure. Committee members agreed that there was only slight opportunity for improvement and voted to recommend the measure for endorsement with reserve status.

0323 Adult Kidney Disease: Hemodialysis Adequacy: Solute (Renal Physicians Association): Endorsed with Reserve Status

Description: Percentage of calendar months within a 12-month period during which patients aged 18 years and older with a diagnosis of End Stage Renal Disease (ESRD) receiving hemodialysis three times a week for >= 90 days have a spKt/V >= 1.2; Measure Type: Intermediate Clincal Outcome; Level of Analysis: Clinician: Group/Practice, Clinician: Individual, Clinician: Team; Setting of Care: Ambulatory Care: Clinician Office/Clinic, Dialysis Facility, Home Health, Post Acute/Long Term Care Facility: Nursing

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Home/Skilled Nursing Facility, Other; Data Source: Administrative claims, Electronic Clinical Data, Electronic Clinical Data: Electronic Health Record, Electronic Clinical Data: Registry

This intermediate clinical outcome measure was originally endorsed in 2007 and is specified at the clinician level. The measure is currently used in the CMS Physician Compare and PQRS. The measure is also used for quality improvement via the RPA Quality Improvement Registry. The rationale for the measure is that an adequate dialysis dose is strongly associated with better outcomes, including decreased mortality, fewer hospitalizations, decreased length of hospitalizations, and decreased

hospital costs. The measure is presented as a clinician level measure in contrast to the CMS facility-level measure (NQF# 0249). Similar to measure NQF #0249, the Committee agreed that the evidence is strong. Upon review of the data provided on performance gap, the Committee agreed that there is little opportunity for improvement and the measure did not pass this subcriterion. However, upon

consideration of the data provided on evidence, reliability, validity, and feasibility, the Committee agreed to recommend the measure for endorsement with reserve status.

1454 Proportion of Patients with Hypercalcemia (University of Michigan/Centers for Medicare & Medicaid Services): Endorsed with Reserve Status

Description: Percentage of adult dialysis patients with a 3-month rolling average of total uncorrected calcium (serum or plasma) greater than 10.2 mg/dL (hypercalcemia); Measure Type: Outcome; Level of Analysis: Facility; Setting of Care: Dialysis Facility; Data Source: Electronic Clinical Data

This measure was originally endorsed in 2011 and is specified at the facility level. The measure is currently used in the CMS Dialysis Facility Compare public reporting program. While the Committee agreed that evidence was largely associative, they allowed the measure to move forward on an evidence exception due to it being considered an important safety measure that fills a gap area in bone and mineral disease. The Committee initially concluded that there was very little opportunity for

improvement and that the 2.1% gap identified by the developer did not warrant a national performance measure. However, based on new data provided by the developer during the post-comment call, the Committee agreed to consider the measure for endorsement with reserve status, noting there were no other bone and mineral measures available in the field. After review of the reliability, validity, feasibility, and usability of the measure, the Committee agreed to recommend the measure for endorsement with reserve status.

Measures Not Endorsed

1660 ESRD Patients Receiving Dialysis: Hemoglobin Level <9g/dL (Renal Physicians Association): Not Endorsed

Description: Percentage of calendar months within a 12-month period during which patients aged 18 years and older with a diagnosis of ESRD who are receiving hemodialysis or peritoneal dialysis have a Hemoglobin level <9g/dL; Measure Type: Outcome; Level of Analysis: Clinician: Group/Practice, Clinician: Individual, Clinician: Team; Setting of Care: Ambulatory Care: Clinician Office/Clinic, Dialysis Facility, Home Health, Post Acute/Long Term Care Facility: Nursing Home/Skilled Nursing Facility, Other; Data Source: Administrative claims, Electronic Clinical Data, Electronic Clinical Data: Electronic Health Record, Paper Medical Records, Electronic Clinical Data: Registry

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This is a newly submitted measure for endorsement and is specified at the clinician level. While the Committee agreed that there was strong evidence supporting that the hemoglobin target should generally be in the range of 11.0 to 12.0 g/dL, the Committee could not come to consensus on whether the evidence supported <9g/dL as an acceptable cutoff. The Committee agreed that it was an important safety measure; however, the Committee eventually concluded that the gap of 5.4% presented by the developer was not sufficient to warrant a national performance measure. As a new measure, this measure could not be considered for inactive endorsement with reserve status. The developer

submitted a reconsideration request. After some discussion and an additional vote on the performance gap subcriterion, the Committee decided to stand by its original decision to not recommend this measure.

2699 Anemia of Chronic Kidney Disease: Dialysis Facility Standardized Transfusion Ratio (STrR) (University of Michigan/Centers for Medicare & Medicaid Services): Not Endorsed

Description: The risk-adjusted facility-level transfusion ratio (STrR) is specified for all adult dialysis patients. It is a ratio of the number of eligible red blood cell transfusion events observed in patients dialyzing at a facility, to the number of eligible transfusions that would be expected under a national norm, after accounting for the patient characteristics within each facility. Eligible transfusions are those that do not have any claims pertaining to the comorbidities identified for exclusion, in the one year look-back period prior to each observation window; Measure Type: Outcome; Level of Analysis: Facility; Setting of Care: Dialysis Facility; Data Source: Administrative claims, Electronic Clinical Data

This is a newly submitted measure for endorsement and is specified at the facility level. The measure is currently used in Dialysis Facility Compare, and is finalized to be used in PY 2018 in the End Stage Renal Disease Incentive Program. The measure looks at a dialysis facility's Standardized Transfusion Ratio (STrR). The rationale behind the measure is that there have been regulatory and policy changes affecting erythropoietin-stimulating agent (ESA) use in dialysis that could result in more transfusions. The

Committee disagreed whether STrR should be considered an outcome due to ambiguity around how quality of care can be interpreted and improved, thus, were not able to come to consensus on whether the evidence supported a relationship between the measured health outcome and at least one clinical action. While the developer displayed variation in performance between facilities in the 25% to 75% quartiles, many Committee members noted that it is difficult to determine and interpret a gap without a STrR target. The Committee was not able to come to consensus on whether the magnitude of the performance gap is sufficient to warrant a national standard. Due to concerns that the measure reflects transfusion practices and behaviors at the hospital level instead of quality of care at dialysis facilities, and concerns about possible differential treatment of data depending on the source, the Committee concluded that this measure was not reliable. The developer did not submit a reconsideration request. 2700 Ultrafiltration Rate Greater Than 13 ml/kg/hr (University of Michigan/Centers for Medicare & Medicaid Services): Not Endorsed

Description: Percentage of patients months for patients with an ultrafiltration rate greater than 13 ml/kg/hr; Measure Type: Intermediate Outcome; Level of Analysis: Facility; Setting of Care: Dialysis Facility; Data Source: Electronic Clinical Data

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This is a newly submitted measure for endorsement and is specified at the facility level. The measure is constructed very similarly to #2701, stewarded by KCQA, but with differences in the number of

ultrafiltration rate measurements required, as well as lack of timing components. The Committee raised concerns about the strength of the evidence on the ultrafiltration rate alone and thus was unable to reach consensus on the evidence criterion. The discussion continued through performance gap and reliability components. Based on the inter-unit reliability testing conducted, the Committee indicated that the measure could be reliably calculated. To demonstrate validity, the developer conducted Poisson regression analysis with two existing measures and the results of those tests raised some concerns from the Committee, as the association was not in the direction expected. The Committee failed the measure at validity and did not recommend it for endorsement. The developer submitted a reconsideration request. After additional discussion, the Committee did not reach consensus on validity and usability, however, agreed that the measure was feasible since it is collected data via CROWNWeb. Despite the reconsideration, the Committee ultimately voted to not recommend the measure for endorsement. 2702 Post-Dialysis Weight Above or Below Target Weight (Kidney Care Quality Alliance): Not Endorsed Description: Percentage of patients with an average post-dialysis weight >/= 1 kg above or below the prescribed target weight; Measure Type: Intermediate Clinical Outcome; Level of Analysis: Facility; Setting of Care: Other; Data Source: Electronic Clinical Data

This is a newly submitted measure for endorsement and is specified at the facility level. The developer emphasized that this measure complements and serves as a check and balance to measure #2701. Grade A KDOQI Guideline was provided which states that patients should be ultrafiltered to a target optimal dry weight. In addition, the developers used an expert consensus panel to review and advise the developer on the measure construct based on 14 studies that assessed issues related to the use of technology in weight management. These studies focused on electronic tools used to define target weight, the intradialytic weight gain including various populations, and what happens when one tries to achieve target weight and various adverse events. The Committee saw a compelling need to have measures for volume. However, it was also noted that given the arbitrary manner in which clinicians set the dry weight and given the lack of data, the evidence presented did not suffice. The Committee voted to continue evaluation and voted insufficient evidence with exception. Based on continued review of the scientific acceptability evaluation, feasibility, and usability of this measure, the Committee did not reach consensus on overall suitability for endorsement. After reviewing the information provided by the developer during the July 30 post-comment call, the Committee was still not able to reach consensus on this measure and did not recommend it for endorsement.

2703 Minimum Delivered Hemodialysis Dose (University of Michigan/Centers for Medicare & Medicaid Services): Not Endorsed

Description: Percentage of all patient months for patients whose average delivered dose of

hemodialysis using the UKM or Daugirdas II formula) was between spKt/V >= 1.2 and spKt/V =< 5.0; Measure Type: Intermediate Clinical Outcome; Level of Analysis: Facility; Setting of Care: Dialysis Facility; Data Source: Administrative claims, Electronic Clinical Data

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This newly submitted intermediate outcome measure is specified at the facility level. The measure includes both the adult and pediatric populations. The Committee noted that, as in many pediatric measures, there is not much evidence for the pediatric population. The measure is based on adult data with the assumption that children should be doing at least as well as adults do, and the Committee noted that is a reasonable position to take. The Committee had concerns with dialysis 3 versus 4 times per week. Evidence is related to 3 times per week although a very low percentage of pediatric patients are dialyzed 4 times per week. The Committee suggested that the developer change the limit to 3 times a week single pool. The Committee did not reach consensus on the evidence criterion. Data on

performance gap presented by the developer demonstrated that there is very little room for

improvement. The measure did not pass the performance gap subcriterion. The developer submitted a reconsideration request. After some discussion, the Committee chose not to reconsider this measure and stood by its original decision to not recommend this measure.

2705 Delivered Dose of Dialysis Above Minimum (University of Michigan/Centers for Medicare & Medicaid Services): Not Endorsed

Description: Percentage of all patient months for patients whose average delivered dose of dialysis (either hemodialysis or peritoneal dialysis) met the specified threshold during the reporting period; Measure Type: Intermediate Clinical Outcome; Level of Analysis: Facility; Setting of Care: Dialysis Facility; Data Source: Administrative claims, Electronic Clinical Data

This newly submitted measure is specified at the facility level. The measure was developed for use by CMS for its public reporting initiatives. The measure is a combination of the respective pediatric hemodialysis (NQF #1423) and peritoneal dialysis adequacy (NQF# 2706) measures, and the respective adult hemodialysis (NQF #2704) and peritoneal (NQF #2703) measures. The Committee noted that the same issues with evidence that were discussed during review of the pediatric hemodialysis and

peritoneal dialysis adequacy measures and the adult hemodialysis and peritoneal measures apply to this measure. The numerator includes hemodialysis patients dialyzing 3 or 4 times a week, but the evidence cited is for dialysis 3 times a week using the Daugirdas formula. Committee members noted that the formula cannot be used for varying weekly dialysis frequency and that a standard weekly Kt/V should be used instead. The Committee also noted the lack of evidence to support the upper limit (Kt/V<5). Overall, the Committee did not pass this measure on Importance due to concerns with the evidence subcriterion. The developer submitted a reconsideration request. Based on new information provided by the developer, the Committee decided to reconsider this measure. The measure was able to pass the evidence criteria, but the Committee did not feel there was enough of a gap to justify a national

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References

1_{U.S. Renal Data System, USRDS 2010 Annual Data Report: Atlas of Chronic Kidney Disease and} End-Stage Renal Disease in the United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2010. Available at http://www.usrds.org/atlas.htm. Last accessed December 2015.

2_{CROWNWeb. What is CROWNWeb? website. CROWNWeb: History, Purpose, and Usage [video].} http://mycrownweb.org/help/what_is_crownweb/. Last accessed December 2015.

3_{United States Renal Data System, 2014 Annual Data Report: Epidemiology of Kidney Disease in the} United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2014.

4_{CROWNWeb. What is CROWNWeb? website. CROWNWeb: History, Purpose, and Usage [video].} http://mycrownweb.org/help/what_is_crownweb/. Last accessed December 2015.

NQF-Endorsed Measures for Renal Conditions, 2015

NQF-Endorsed Measures

for Renal Conditions,

2015

TECHNICAL REPORT

December 2015

Contents

NQF-Endorsed Measures for Renal Conditions, 2015

TECHNICAL REPORT

Executive Summary

Introduction

NQF Portfolio of Performance Measures for Renal Conditions

National Quality Strategy

Use of Measures in the Portfolio

Committee Input on Gaps in the Portfolio

Renal Measure Evaluation

Comments Received Prior to Committee Evaluation

Comments Received After Committee Evaluation

Overarching Issues

Current Implementation and Use

Use of Reserve Status

Level of Evidence and Population Size: Pediatric Measures

CROWNWeb Data

Summary of Measure Evaluation

Endorsed Measures

Measures Endorsed with Reserve Status

Measures Not Endorsed

References